English Translation GOVERNMENT OF THE RUSSIAN FEDERATION ROADMAP FOR DEVELOPMENT OF COMPETITION IN HEALTHCARE. January 12, 2018, No. 9-r.

Transcription

1 Bruce A. McDonald GOVERNMENT OF THE RUSSIAN FEDERATION ROADMAP FOR DEVELOPMENT OF COMPETITION IN HEALTHCARE January 12,, No. 9-r Moscow Last Accessed: 02/14/ ПРАВИТЕЛЬСТВО РОССИЙСКОЙ ФЕДЕРАЦИИ Р А С П О Р Я Ж Е Н И Е от 12 января г. 9-р МОСКВА 1. Утвердить прилагаемый план мероприятий ("дорожную карту") "Развитие конкуренции в здравоохранении" (далее - план). GOVERNMENT OF THE RUSSIAN FEDERATION O R D E R January 12,, No. 9-r MOSCOW 1. To ratify the attached plan of action ( Roadmap ), Development of Competition in Healthcare ( the Plan ). 2. Реализация мероприятий, предусмотренных планом, осуществляется заинтересованными федеральными органами исполнительной власти в рамках установленной Правительством Российской Федерации предельной численности работников и бюджетных ассигнований, предусмотренных указанным федеральным органам исполнительной власти в федеральном бюджете на руководство и управление в сфере установленных функций 3. Руководителям федеральных органов исполнительной власти, ответственных за реализацию плана: обеспечить реализацию плана; представлять ежеквартально, до 5-го числа месяца, следующего за отчетным кварталом, в ФАС России информацию о ходе реализации плана. 2. Realization of measures called for by the Plan shall be carried out by responsible federal authorities in a framework established by the with designated agencies and budgetary allocations called for by the designated federal agency in the federal budget for leadership and management in the sphere of its designated functions. 3. The directors of the federal agencies responsible for implementation of the Plan shall: assure that the Plan is carried out; submit quarterly reports, prior to the 5 th day of the month following the accounting period, to the with information about progress on implementation of the Plan.

2 4. ФАС России: обеспечить мониторинг и контроль реализации плана; представлять ежеквартально, до 25-го числа месяца, следующего за отчетным кварталом, в Правительство Российской Федерации информацию о ходе реализации плана. Председатель Правительства Российской Федерации Д. Медведев 4. The shall: be responsible for monitoring and supervising the implementation of the Plan; submit quarterly reports, prior to the 25 th day of the month following the accounting period, to the, with information about progress on implementation of the plan. Chairman of the D. Medvedev. -.

3 Bruce A. McDonald Roadmap for Development of Competition in Healthcare, Jan. 12, APPROVED By Order No. 9-r of the January 12, I. Market for Pharmaceutical Products 1. State Registration of Pharmaceutical Products Establishment of administrative penalties for producers of biotechnological and orphan drugs who fail to submit samples for the conduct of clinical investigations within a period of four years from the date of state registration Federal Law Expedited marketing of generic pharmaceuticals and access of patients to innovative drugs Sept. & Trade; Establishment of administrative penalties for producers of biotechnological and orphan drugs for violation of price controls on pharmaceutical products on the list of lifesaving and essential medicines Federal Law Expedited marketing of generic pharmaceuticals and access of patients to innovative drugs Sept. & Trade; Development of a mechanism of access to market for innovative drugs going through clinical investigations and registered in the European Union, the United States of America and Japan, including an inscription in the labeling that the medicine has not undergone clinical investigation on the territory of the Russian Federal Law Expedited marketing of generic pharmaceuticals and access of patients to innovative drugs Jan. & Trade;

4 Roadmap for Development of Competition in Healthcare, Jan. 12, 2. Interchangeability of Pharmaceutical Products Establishment of list of reference drugs Submission of list of reference drugs to ; publication of list on websites of Health and to provide developers of generic drugs with disclosure of information about reference drugs for state registration of generic drugs; reduction of examination periods for applications by drug manufacturers for registration of maximum mark-ups on medicines on list of lifesaving and essential medicines June Health Establishment of administrative penalties for pharmaceutical producers who failure to provide full and accurate information about the contents and characteristics of medicines in labeling and instructions Federal Law Creation of conditions for competition among pharmaceutical products; ensuring the safety of pharmaceutical products Sept. Establishment of model instructions for the use of interchangeable pharmaceutical products Order by Health Elimination of unjustified variations in instructions for interchangeable pharmaceuticals having a single international nonproprietary name; creation of conditions for competition among pharmaceutical producers Jan. and Trade; Establishment of equivalent therapeutic doses for medicines registered prior to approval of Order No. 538n of the Health dated July 27, 2016 On the Approval of the List of Names of Medicinal Forms of Pharmaceutical Products for Medical Use. 1 Order of Ministry of Health Reduction of limitations on competition among producers of pharmaceutical products registered prior to approval of the List of Names of Medicinal Forms of Pharmaceutical Products for Medical Use Dec. and Trade; 1 On August 17, 2016, Justice registered Order No. 538n of the Health dated July 27, 2016 "On the Approval of the List of Names of Medicinal Forms of Pharmaceutical Products for Medical Use." The name of the dosage form includes a 4

5 Roadmap for Development of Competition in Healthcare, Jan. 12, Examination of documents in registration dossiers of imported pharmaceutical products for conformance with the dossiers for identical products registered abroad and conformance with dossiers on reference and generic drugs registered in Report to Creation of conditions for competition among pharmaceutical producers Aug. Economic Development; Establishment of a commission in the Health with responsibility for creation of a list of lifesaving and essential medicines considering the availability of equivalent applications Creation of equal conditions for producers of interchangeable pharmaceutical products; prevention of unjustified inclusion of pharmaceuticals in the list of lifesaving and essential medicines Aug. Economic Development; Establishment of professional responsibility of medical workers for violation of Law on Circulation of Medicines in the public health sector Report to Elimination of disparity in responsibility for the level of public danger in violations of Russian law on Circulation of Medicines; elimination of limitations in competition in the sphere of circulation of interchangeable pharmaceutical products; increase of access to pharmaceutical products by patients based on right to choose pharmaceuticals at the most reasonable price. Sept. ; Health; Federal Service for Healthcare and Social Development basic element designating an independent, homogeneous group of forms (tablets, capsules, solution, ointment and other forms) that can be supplemented by one or more additional elements characterizing the properties of the dosage form (type of modified release of active ingredients (sustained release capsules) ), sign of readiness for use (powder for solution for injection), administration method (liquid for inhalation), route of administration (solution for nutritional injections), features of manufacturing technology (film-coated tablets), dose-sharing (nasal dosed spray), age group of patients (rectal suppositories for children), destination or area of application (dental paste). The order is applied to the names of medicinal forms of medicinal products, applications for state registration of which are submitted to the Health after the entry into force of this order. 5

6 Roadmap for Development of Competition in Healthcare, Jan. 12, Notice to the medical community and patients about interchangeable pharmaceutical products Report to Education of the public and medical workers about the availability of less expensive analogs to expensive pharmaceuticals; creation of sustainable demand for pharmaceuticals in the lower income segment; preventing lower priced pharmaceuticals from shaking out of the market Sept. Education and Science; Communications and Mass Media; and Trade; Federal Service for Healthcare; 2 Introduction of requirements for pharmacy organizations to first offer purchasers the least expensive drugs and notify purchasers regarding the availability less expensive analogs and their prices Order by Health Increase of accessibility in terms of price and assortment by means of preventing lower priced pharmaceuticals from shaking out of the market Nov. Determine feasibility of amendments to Article 18 of Federal law On the Circulation of Medicines relating to the establishment of a prohibition against state registration of generic drugs in dosages differing from the dosages of reference drugs, as well as state registration of generic drugs, instructions for medical use of which differ from the instructions for medical use of reference drugs Report to Elimination of opportunity for registration of medicines in therapeutically unjustified dosages; prohibition against unfair use of information in instructions for medical use of pharmaceuticals at the time of purchase. Nov. 2 Ed. Note: 6

7 Roadmap for Development of Competition in Healthcare, Jan. 12, Establishment of procedure for changes in instructions for medical use of drugs registered in the framework of a single international nonproprietary name, in particular mandatory changes in instructions for medical use of drugs involving counter indications and side effects; resolve issues relating to administrative penalties on holders or owners of marketing authorizations for failure to fulfill designated requirements Federal Law Elimination of unjustified distinctions in instructions for medical use of drugs having one international nonproprietary name Oct. Establishment of procedure for the formulation of lists of drugs, designated dosage forms and applications Decree of Creation of equal conditions for circulation of equivalent dosage forms of drugs July and Trade; 7

8 Roadmap for Development of Competition in Healthcare, Jan. 12, 3. Establishment of Mechanism for Regulation of Prices for Pharmaceutical Products on the List of Lifesaving and Essential Medicines Implementation of amendments to Federal Law On Circulation of Medicines and rules for establishment of maximum mark-ups of wholesale and retail prices by producers of pharmaceutical products on the list of lifesaving and essential medicines, for subjects of the Russian confirmed by Decree No. 865 of the dated October 29, 2010, On government regulation of prices for pharmaceutical products included on the list of lifesaving and essential medicines, calling for the setting of retail prices on drugs included on the list of lifesaving and essential medicines, depending on the legal status of the taxpayer Federal Law, Decree of Elimination of contradictions in legislation regarding the calculation of selling prices for medicines included in the list of lifesaving and essential medicines, depending on the legal status of the taxpayer Dec. ; Health; Economic Development; and Trade; Ministry of Finance 8

9 Roadmap for Development of Competition in Healthcare, Jan. 12, Establishment of procedure for state registration of maximum mark-ups on prices for drugs on the list of lifesaving and essential medicines Federal Law; 4. Regulation of State and Municipal Procurement of Medicines Elimination of discrimination between domestic and foreign drug producers; increase in informational character and accuracy of government register of maximum mark-ups on prices of medicines on list of lifesaving and essential medics; prevention of opportunity for linkage of marginal mark-ups to prices of drugs not in circulation; providing of verified data to government and municipal purchasers as necessary for calculation of initial (and maximum) prices of state and municipal contracts; establishment of possibility for retraction or reexamination of decisions on registration of maximum mark-ups resulting from mistakes by responsible federal authorities; elimination of risks of substantial increase in budgetary expenses in the inclusion of new drugs in the list of lifesaving an essential medicines Feb. Economic Development; and Trade; Ministry of Finance; Development of model contracts calling for identical technical tasks by category of drug Order by Health Elimination of limitations on competition in state and municipal purchases; creation of equal conditions for suppliers of drugs at auction April Finance; and Trade; 9

10 Roadmap for Development of Competition in Healthcare, Jan. 12, Establishment of criteria for market conditions permitting sole-source supply of pharmaceutical products; establishment of procedure for selection of contractor for supply of drugs with the aim of developing drafts of corresponding regulations by the President of and the for determination of sole source drug suppliers Federal Law, Creation of mechanism for decisions by the President of and the on the determination of sole source suppliers of drugs based on transparent procedures and objective criteria; increase in the efficacy of the budgetary expenses Feb. and Trade; Ministry of Finance; Ministry of Health; Establishment of opportunity for sole- source supply only in connection with medicines lacking an analog on the territory of Federal Law; Prevention of unjustified limitations in competition in generic medicines; increase in efficacy of budgetary expenses Feb. and Trade; Ministry of Finance; Ministry of Health; Establishment of limitations on the execution of long-term government contracts for the supply of medicines, including the establishment of an opportunity for execution of long-term government contracts only for medicines protected by patents and subject to a meaningful reduction of price on such medicines; limitation on the period of validity of long-term government contracts to the term of the patent on the medicine or the date of release onto the market of another medicine having the same indications and use Federal Law Elimination of unjustified limitation on competition in the appearance of generic medicines; increase of efficacy of budgetary expenses; stimulation of release onto the market of generic medicines, as well as other medicines having the same indications; lowering of prices for medicines not having analogs, on account of guaranteed volumes of production; reduction of costs of state purchasers tied to procurement of medicines June ; Finance; Health; Industry and Trade 10

11 Roadmap for Development of Competition in Healthcare, Jan. 12, Establishment of particulars in the description of medicines for execution of procurement, including medicinal forms and dosages of medicines; establishment of prohibition on combining in one lot services for supply, storage and release of medicines; establishment of requirements for indicating in documentation on the procurement of the remaining period of validity of medicines, expressed in the designated period (for example, in years, months, days), during which the medicines preserve their efficacy for their designated purpose Elimination of limitations and suppression of competition by state and municipal purchasers; increase in quantity of participants of procurement; increase in efficacy of budgetary expenses; creation of equal conditions for suppliers of interchangeable drugs having distinctions in nominal periods of validity; prevention of designation of remaining period of validity in percentages Sept. ; Finance; Health; Industry and Trade Establishment of opportunity for determination of country of origin of medicines based on marketing authorization without the need for receipt of Certificate ST-1 Federal Law; Elimination of excessive administrative barriers; lowering of restraints on suppliers of medicines participating in public procurement; lowering of prices on drugs Oct. and Trade; Ministry of Economic Development; 5. Enactment of legal regulation in the sphere of intellectual property protection Clarification of conditions for patentability of inventions in connection with patenting of any new property or new application of a known existing substance of a drug Report to Determination of questions relating tithe patentability of modifications to existing medicines, including new indications, therapeutic methods, combinations of existing substances, medicinal forms, and means of production Sept. Economic Development; Education and Science; Industry and Trade; Rospatent; 11

12 Roadmap for Development of Competition in Healthcare, Jan. 12, Establishment of periods of examination of disputes relating to the protection of intellectual property Order of Ministry of Education and Science Change in the procedure for exemption of disputes connected to protection of intellectual property; expediting of release onto the market of generic and biosimilar drugs Aug. Education and Science; Rospatent; Development of procedures as contemplated by Article 1360 of the Civil Code for issuance of permission to use inventions, utility models and industrial designs of pharmaceutical substances without the agreement of the patent holder Federal Law; Establishment of conditions for implementation of Article 1360 of the Civil Code for the purpose of lowering prices on expensive drugs protected by patent and necessary for combatting epidemics threatening national security Dec. ; Health; Industry and Trade; Education and Science; Rospatent 12

13 Roadmap for Development of Competition in Healthcare, Jan. 12, 6. Development of competition among pharmacy organizations Establishment of rules for long-distance trade in medicines by pharmacy organizations, including a mechanism for the limitation of access to websites not in compliance with designated rules Federal Law; Creation of equal conditions for functioning of pharmacy organizations, suppression of trade in counterfeit pharmaceuticals and inferior medicines sold on the Internet; timely blocking of Internet sites not in compliance with rules for long-distance trade Nov. Telecommunications and Mass Media; Economic Development; Agriculture; Federal Service for Healthcare; Federal Service for Supervision of Communications, Information Technology and Mass Media; Development of administrative procedure for exercise of control over long-distance trade in medicines Order of Ministry of Health Regulation of procedure and periods of execution by authorized federal executive government authority of state functions for the control over distance trade in medicines July Federal Service for Healthcare Measures to support pharmacy organizations of various forms of ownership in municipalities of up to 100,000 population for the purpose of providing related recommendations to subjects of Report to Development of competition among pharmacy organizations in municipalities of up to 100,000 population; improvement in physical access to medicines by under populated and remote population centers Nov. ; Economic Development; Health 13

14 Roadmap for Development of Competition in Healthcare, Jan. 12, 7. Legal regulation in the circulation in medical devices II. Markets for Medical Devices Establishment of a procedure for determination of interchangeability of medical devices, including consumable materials Creation of conditions for development of competition among producers of medical devices Nov. and Trade; Federal Service for Healthcare; Development of administrative procedure for determination of interchangeability of medical devices Order by Health Regulation of procedure and periods for execution by federal agencies for determination of interchangeability of medical devices March and Trade; Federal Service for Healthcare Determination of characteristics of medical devices of the open and closed types, as well as establishment of obligations of state and municipal purchasers to procure medical devices of the open type Federal Law; Creation of conditions for development of competition in the market for medical devices Jan. Finance; Requirements for inclusion of information about the period of use, including guarantee of usefulness, cost of technical service and repair of medical devices, as well as the cost of training of medical workers of rules of use and utilization of medical devices, in technical documentation for medical devices Creation of conditions for development of competition in the market for technical servicing of medical devices March Economic Development; 14

15 Roadmap for Development of Competition in Healthcare, Jan. 12, Reexamination procedures for the setting of payments and examination of quality, efficacy and safety of medical devices, eliminating arbitrary decisions by the executive agency especially the determination of place of conduct, quantity and character of investigations of medical devices in connection with government registration; establishment of procedure for extra-judicial challenge to results of examination of quality, efficacy and safety of medical devices Federal Law Unification of procedure for government registration of medical devices; elimination of corruption-related factors Sept. and Trade; Ministry of Economic Development; Federal Service for Healthcare; Establishment of requirements for servicing of medical devices; providing information to purchasers for the functioning of medical devices, including the providing of keys, access passwords, programs and other information necessary for the assembly, operation, application, exploitation, including technical servicing of medical devices; prohibition against the unjustified limitation by producers of medical equipment on the possibility for use of consumable materials and reagents of other producers; placement on official website of the Federal Service for Healthcare of documentation for every medical device; establishment of requirements for producers of medical devices on nondiscriminatory basis to conduct training of persons engaged in technical servicing of medical devices Federal Law Creation of conditions for development of competition in the markets for medical devices, consumable materials, and technical servicing Mar. and Trade; Federal Service for Healthcare; 8. State and municipal procurement of medical devices Development of model contracts calling for unified technical requirements for separate categories of medical devices Order by Health Elimination of limitations and suppression of competition by state and municipal purchasers; creation of equal conditions for suppliers of medical devices at auction April Finance; and Trade; 15

16 Roadmap for Development of Competition in Healthcare, Jan. 12, Preparation of proposals for the implementation of amendments to the list of goods and services in which the purchaser is obligated to conduct an auction in electronic format (electronic auction), approved by Order No. 471-r of the dated march 21, 2016, in particular the inclusion in the list of all medical devices without exception Report to Elimination of the opportunity for arbitrary actions by state and municipal purchasers in ranking and the unjustified valuations of applications for the holding of tenders June Finance; Establishment of requirements for participants of state and municipal procurement of medical devices the utilization of which requires the use of consumable materials and identification in technical documentation of the producer of medical device requirements for consumable materials, providing requisite utilization of medical devices, as well as establishment of particulars for purchases by state and municipal purchasers of medical devices of the open type Creation of conditions of economic development in the market for technical servicing of medical devices Nov. Finance; Establishment of requirements for the inclusion in documentation for the procurement of medical devices of information about the expiration date of medical devices (for example, in years, months, and days), Creation of equal conditions for suppliers of interchangeable medical devices having various nominal periods of validity; prohibition against indication of remaining period of validity of medical devices in percentages; increase in the quantity of participants of procurements; increase in effectiveness of budgetary expenses Oct. ; ministry of Finance; Health; Industry and Trade Establishment of requirements for state and municipal purchasers of medical devices to specify the initial (and maximum) price of contract accounting for the acquisition of consumable materials and technical servicing prior to the expiration date Creation of conditions for development of competition in the markets for technical servicing of medical devices March Finance; 16

17 Roadmap for Development of Competition in Healthcare, Jan. 12, III. Market for Medical Services 9. Healthcare legislation, in particular the determination of volumes and types of medical assistance in territorial programs for government guarantees of unpaid medical assistance; annual renewal of government guarantees for unpaid rendering of medical assistance in the implementation of new medical technologies Federal Law; Fulfillment of citizens rights to unpaid medical assistance Feb. Economic Development; Federal Service for Healthcare; 10. Amendments to Article 18 of Federal Law On licensing of different types of activities and Paragraph 3 of Decree No. 957 of the dated Nov. 21, 2011, On the organization of licensing of different types of activities, calling for a change of the procedure for reissuance of a license for the rendering of medical and pharmaceutical activity in connection with new addresses of places of business in the procedure for execution by licensing agencies of a subject of and attachment to license with indication of new addresses of place of business, without change to the requisites of the license itself or need for presentation of original license to the licensing agency Federal Law; Removal of unjustified administrative barriers in the reissuance of a license for rendering of medical and pharmaceutical activity; expediting of development of medical and pharmacy organizations in subjects of April Economic Development; Federal Service for Healthcare; 17

18 Roadmap for Development of Competition in Healthcare, Jan. 12, 11. Approval and implementation of clinical recommendations (treatment protocols) Orders of the Health of the Russian Increase in quality of medical assistance Dec. Health 12. Development of proposals for the establishment of conditions under which government (municipal) medical organizations may render paid medical services Report to Creation of equal conditions for the rendering of paid medical services by government, municipal and private medical organizations; prohibition of rendering by government medical organizations of paid medical services which should be rendered in the framework of territorial programs of government guarantees for unpaid rendering to citizens of medical assistance Nov. ; Health 13. Proposals for a mechanism to distribute medical assistance to participants in territorial programs of government guarantees for unpaid rendering to citizens of medical assistance Report to Creation of equal conditions of participation of medical organizations in the system of mandatory medical insurance; prevention of abuses of commissions for the development of territorial programs of mandatory medical insurance for the distribution of volumes of medical assistance by participants of mandatory medical insurance Nov. ; Health; Federal Compulsory Medical Insurance Fund 18

19 Roadmap for Development of Competition in Healthcare, Jan. 12, IV. Market for Biologically Active Additives 14 Legal regulation of biologically active additives by means of prohibition on government registration of biologically active additives of pharmaceutical substances or products having pharmaceutical substances; prohibition on government registration of identically named or confusingly similar biologically active additives and medicines Application to Eurasian Economic Commission for amendments to technical regulations of the Customs Union TR TS 021/2011, 022/2011, with the aim of suppressing the unlawful circulation of biologically active additives and passing-off as to the content and substance of biologically active additives; providing of safety to citizens Sept. Federal Service for the Sphere of Consumer Protection and Human Welfare; 15. Review of all previously registered biologically active additives, identically named or confusingly similar to medicines Draft recommendation to the Committee of Eurasian Economic Commission for adoption of decision to withdraw from circulation biologically active additives identically named or confusingly similar to medicines, including biologically active additives registered in countries of the Eurasian Economic Union Nov Federal Service for the Sphere of Consumer Protection and Human Welfare; 19